We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00541723
First Posted: October 10, 2007
Last Update Posted: March 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
  Purpose
To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).

Condition Intervention Phase
Lateral Periorbital Wrinkles Drug: IncobotulinumtoxinA (Xeomin) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline. [ Time Frame: Week 4 ]
    Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.


Secondary Outcome Measures:
  • Response assessed by the investigator at maximum smile for either eye area compared to baseline. [ Time Frame: Weeks 2, 4, 12, and 20 ]
    Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.

  • Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline. [ Time Frame: Weeks 2, 4, 12, and 20 ]
    Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale.


Enrollment: 111
Study Start Date: September 2007
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IncobutolinumtoxinA (Xeomin), 4-injection scheme

IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient:

Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 4 x 0.06 mL (4 x 3 units = 12 units); mode of administration: intramuscular injection.

Drug: IncobotulinumtoxinA (Xeomin)
Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye)
Placebo Comparator: Placebo 4-injection scheme
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; total volume 0.24 mL per side, i.e. 4 x 0.06 mL placebo solution; mode of administration: intramuscular injection.
Drug: Placebo
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
Experimental: IncobotulinumtoxinA (Xeomin), 3-injection scheme

IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient:

Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 3 x 0.08 mL (3 x 4 units = 12 units); Mode of administration: intramuscular injection.

Drug: IncobotulinumtoxinA (Xeomin)
Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye)
Placebo Comparator: Placebo 3-injection Scheme
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; total volume 0.24 mL per side, i.e. 3 x 0.08 mL placebo solution; mode of administration: intramuscular injection.
Drug: Placebo
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.

Detailed Description:
Conducted in Europe
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

- Moderate (grade 2) to severe (grade 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to the 4-point scale at maximum smile

Main Exclusion Criteria:

- Significant facial asymmetry

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541723


Locations
France
Cannes, France
Nice, France
Paris, France
Germany
Duesseldorf, Germany
Karlsruhe, Germany
Munich, Germany
Starnberg, Germany
Italy
Roma, Italy
United Kingdom
Bexley. Kent, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Sutton Coldfield, United Kingdom
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Principal Investigator: David Eccleston, MD MediZen, Sutton Coldfield, United Kingdom
  More Information

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00541723     History of Changes
Other Study ID Numbers: MRZ 60201-0617/1
2006-005396-17 ( EudraCT Number )
First Submitted: October 8, 2007
First Posted: October 10, 2007
Last Update Posted: March 8, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
incobotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents


To Top